FDA.reportPublic FDA data

70213 Needle Counter 1/2 Adhesive 1/2 Foam Slits

Primary DI
00787551009507
Brand
70213 Needle Counter 1/2 Adhesive 1/2 Foam Slits
Company
XODUS MEDICAL, INC.
Model
70213
Catalog number
70213
Device description
70213 Needle Counter 1/2 Adhesive 1/2 Foam Slits
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10787551009504PackageGS124In Commercial Distribution
20787551009501PackageGS196In Commercial Distribution
00787551009507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1078755100950410787551009504
2078755100950120787551009501
00787551009507007875510095077875510095070787551009507

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
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(724)337-5500plloyd@xodusmedical.com

Regulatory Flags#

DUNS number
868042664
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

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00787551041583SPK11715 Jackson KitSPK11715SPK117152026-04-30
0078755104159040673 Hot Pink Pad EXT - with Arm Protectors40673406732026-04-30
0078755104160640674 Hot Pink Pad EXT40674406742026-04-30
00787551041613SPK11759 Jackson Table KitSPK11759SPK117592026-04-30
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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