FDA.reportPublic FDA data

Needle counter, 40-80 count, double foam, double magnet, adhesive tabs

Primary DI
10850007280199
Brand
Needle counter, 40-80 count, double foam, double magnet, adhesive tabs
Company
NEWGEN SURGICAL, INC.
Model
NGSNC80FFMMA-90NS
Catalog number
NGSNC80FFMMA-90NS
Device description
Needle counter, 40-80 count, double foam, double magnet, adhesive tabs: Designed to support safe and efficient sharps handling, this product features easy-to-read numbers for securing needles, a secure closure with audible feedback, and adhesive tabs that attach firmly to any workspace. The full-surface magnet helps capture and secure needles and blades, while the easy-to-separate design supports convenient handling and disposal.
Published
2026-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GABNeedle, Suturing, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850007280199PrimaryGS10
00850007280192Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000728019910850007280199
00850007280192008500072801928500072801920850007280192

GMDN Terms#

Term, Definition table
TermDefinition
Sharp surgical instrument counting tray/pad, single-useA device intended to be used in the operating room (OR) by staff to maintain the count of various sharp surgical instruments (e.g., needles, blades, scissors) to prevent instruments from being inadvertently left in a patient; it may in addition be used for temporary storage of instruments during surgery. The counter is usually flat when in use and employs magnetism, foam rubber, or some other mechanism to hold the counted objects in place. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
415-457-1138sales@newgensurgical.com

Regulatory Flags#

DUNS number
037689420
Device count
90
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850007280182Needle counter, 30-60 count, double magnet, adhesive tabsNGSNC60MA-90NSNGSNC60MA-90NS2026-10-15
10850007280205Needle counter, 100 count, foam block, double magnet, adhesive tabsNGSNC100FMMA-90NSNGSNC100FMMA-90NS2026-10-15
10850007280311Needle counter, 20 count, foam block, magnet, adhesive tabsNGSNC20MA-180NSNGSNC20MA-180NS2026-10-15
30864887000062Needle counter, 20 count, double magnet, adhesive tabsNGSNC20MA-360NSNGSNC20MA-360NS2026-10-15
30864887000079Needle counter, 30 count, double magnet, adhesive tabsNGSNC30MA-360NSNGSNC30MA-360NS2026-10-15
30864887000093Needle counter, 40 count, foam block, double magnet, adhesive tabsNGSNC40FMMA-90NSNGSNC40FMMA-90NS2026-10-15
00850007280345Two Compartment Tray CoatedNGS2CTC-250NSNGS2CTC-250NS2026-10-13
00850007280352One-Compartment Tray CoatedNGS1CTC-250NSNGS1CTC-250NS2026-10-13
10850007280250One-Compartment TrayNGS1CT-250NSNGS1CT-250NS2026-10-13
10850007280267Two Compartment TrayNGS2CT-250NSNGS2CT-250NS2026-10-13
00850007280284Ring Basin - 5500 ccNGS5500RBE-80NSNGS5500RBE-80NS2026-10-09
10850007280021Emesis Basin - 700 ccNGS700EB-250NSNGS700EB-250NS2026-10-09
10850007280038Sponge Bowl - 32 ozNGS32SB-400NSNGS32SB-400NS2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850007280182Needle counter, 30-60 count, double magnet, adhesive tabsNEWGEN SURGICAL, INC.GAB2026-10-15
10850007280205Needle counter, 100 count, foam block, double magnet, adhesive tabsNEWGEN SURGICAL, INC.GAB2026-10-15
10850007280311Needle counter, 20 count, foam block, magnet, adhesive tabsNEWGEN SURGICAL, INC.GAB2026-10-15
30864887000062Needle counter, 20 count, double magnet, adhesive tabsNEWGEN SURGICAL, INC.GAB2026-10-15
30864887000079Needle counter, 30 count, double magnet, adhesive tabsNEWGEN SURGICAL, INC.GAB2026-10-15
30864887000093Needle counter, 40 count, foam block, double magnet, adhesive tabsNEWGEN SURGICAL, INC.GAB2026-10-15
09353903030225OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDGAB2026-07-15
09353903030201Griplasty SystemFIELD ORTHOPAEDICS PTY LTDGAB2026-06-24
16931918121994AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-04-06
16931918157016AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-01-21
16931918179858AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-21
16931918144948AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-20
10192253052329DevonCardinal Health 200, LLCGAB2025-05-29
10192253052138DevonCardinal Health 200, LLCGAB2025-03-27
10192253052145DevonCardinal Health 200, LLCGAB2025-03-27
10192253052152DevonCardinal Health 200, LLCGAB2025-03-27
10192253052169DevonCardinal Health 200, LLCGAB2025-03-27
10192253052176DevonCardinal Health 200, LLCGAB2025-03-27
10192253052183DevonCardinal Health 200, LLCGAB2025-03-27
10192253052190DevonCardinal Health 200, LLCGAB2025-03-27
10192253052206DevonCardinal Health 200, LLCGAB2025-03-27
10192253052213DevonCardinal Health 200, LLCGAB2025-03-27
10192253052220DevonCardinal Health 200, LLCGAB2025-03-27
10192253052237DevonCardinal Health 200, LLCGAB2025-03-27
10192253052244DevonCardinal Health 200, LLCGAB2025-03-27
10192253052251DevonCardinal Health 200, LLCGAB2025-03-27
10192253052268DevonCardinal Health 200, LLCGAB2025-03-27
10192253052275DevonCardinal Health 200, LLCGAB2025-03-27
10192253052282DevonCardinal Health 200, LLCGAB2025-03-27
10192253052299DevonCardinal Health 200, LLCGAB2025-03-27