FDA.reportPublic FDA data

Key Surgical Needle Counters

Primary DI
30849771031155
Brand
Key Surgical Needle Counters
Company
KEY SURGICAL, INC.
Model
NC-60-121B
Device description
Needle Counters, Sterile, 60 Count, Dual Magnetic, Solid Lid, Blade Remover, box/54
Published
2020-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
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
30849771031155PackageGS154In Commercial Distribution
00849771031154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084977103115530849771031155
00849771031154008497710311548497710311540849771031154

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.541.7995regulatory@keysurgical.com
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags#

DUNS number
604056226
Device count
1
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849771052708NAPlastic Sterilization TrayPST1100SB2023-01-26
00849771052159NAES50ES502023-01-26
00849771048237NAK-Wire and Steinmann Pin DispenserKI710172025-08-11
00849771049036NAK-Wires and Steinmann PinsKI711312025-08-11
00849771049289NAK-Wires and Steinmann PinsKI711852025-08-11
00849771049500NAK-Wires and Steinmann PinsKI712532025-08-11
00849771048169NAK-Wire and Steinmann Pin DispensersKI710022025-04-30
00849771049012NAK-Wires and Steinmann PinsKI711242025-04-30
00849771049128NAK-Wires and Steinmann PinsKI711612025-04-30
60849771050416Electro LubeEL101EL1012025-04-24
00849771046356K-Wire and Steinmann Pin DispensersKI71042KI710422025-04-16
00849771046363K-Wire and Steinmann Pin DispensersKI71044KI710442025-04-16
00849771046370K-Wire and Steinmann Pin DispensersKI71046KI710462025-04-16
00849771046387K-Wire and Steinmann Pin DispensersKI71047KI710472025-04-16
00849771046394K-Wire and Steinmann Pin DispensersKI71048KI710482025-04-16
00849771013372Key Surgical Cautery Tip CleanerTC200NSTC200NS2025-04-04
50849771050617NAK-Wire and Pin CoversC1092025-01-29
10724995225022Electro LubeEL201EL2012024-10-03
00849771048190NAK-Wire and Steinmann Pin DispensersKI710062024-10-03
00849771052562Key Surgical Pipe CleanersPC100CPC100C2024-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06931918157019AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-01-21
07350154050004SutureTOOLSuturion ABGAB2025-12-15
26931918179855AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-21
06931918144941AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-20
20192253052326DevonCardinal Health 200, LLCGAB2025-05-29
50192253052136DevonCardinal Health 200, LLCGAB2025-03-27
20192253052142DevonCardinal Health 200, LLCGAB2025-03-27
50192253052150DevonCardinal Health 200, LLCGAB2025-03-27
20192253052166DevonCardinal Health 200, LLCGAB2025-03-27
50192253052174DevonCardinal Health 200, LLCGAB2025-03-27
20192253052180DevonCardinal Health 200, LLCGAB2025-03-27
20192253052197DevonCardinal Health 200, LLCGAB2025-03-27
50192253052204DevonCardinal Health 200, LLCGAB2025-03-27
20192253052210DevonCardinal Health 200, LLCGAB2025-03-27
20192253052227DevonCardinal Health 200, LLCGAB2025-03-27
20192253052234DevonCardinal Health 200, LLCGAB2025-03-27
50192253052242DevonCardinal Health 200, LLCGAB2025-03-27
50192253052259DevonCardinal Health 200, LLCGAB2025-03-27
50192253052266DevonCardinal Health 200, LLCGAB2025-03-27
20192253052272DevonCardinal Health 200, LLCGAB2025-03-27
50192253052280DevonCardinal Health 200, LLCGAB2025-03-27
20192253052296DevonCardinal Health 200, LLCGAB2025-03-27
50192253052310DevonCardinal Health 200, LLCGAB2025-03-27
50192253052334DevonCardinal Health 200, LLCGAB2025-03-27
20192253052340DevonCardinal Health 200, LLCGAB2025-03-27
20192253052357DevonCardinal Health 200, LLCGAB2025-03-27
50192253052365DevonCardinal Health 200, LLCGAB2025-03-27
50192253052372DevonCardinal Health 200, LLCGAB2025-03-27
50192253052389DevonCardinal Health 200, LLCGAB2025-03-27
50192253053355DevonCardinal Health 200, LLCGAB2025-03-27