FDA.reportPublic FDA data

Versitomic Sterile Flexible Pin (5 units - lb1)

Primary DI
30810190016030
Brand
Versitomic Sterile Flexible Pin (5 units - lb1)
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
C
Catalog number
tg108200st
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWKTrephine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWKTrephineOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30810190016030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081019001603030810190016030

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, single-use, sterileA sterile, hand-held, tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
534123013
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818674021545Switchcut Femoral Guide Arm Point110026880148400bsm2026-05-18
10818674021552Switchcut Tibial Guide Arm PCL110026881148500bsm2026-05-18
10810128463291Back Drill Guide Bullet ID 4.5mmS25-3001-T149000su2026-05-13
10810128463307Back Drill Guide Bullet ID 6.0mmS25-3002-T150000su2026-05-13
10810128463574Rasp Up Bend 20°S36-0013-T901131su2026-05-13
10810128463581Rasp Down Bend 20°S36-0024-T901141su2026-05-13
108101284636284.5mm Can. Full Thickness DrillS250045A113045su2026-05-13
108101284636357.0mm Can. Full Thickness DrillS25-7000-AT113070su2026-05-13
108101284636428.0mm Can. Full Thickness DrillS25-8000-AT113080su2026-05-13
108101284636599.0mm Can. Full Thickness DrillS25-9000-AT113090su2026-05-13
10810128463666Back Drill Femoral Guide Arm RightS25-3200-T148200su2026-05-13
10810128463673Back Drill Tibial Guide to PointS25-3300-T148300su2026-05-13
10810128463697Meniscal Root ArmS25-3600-T148600su2026-05-13
10810128462775OsteoTak ArthrexAR-1902611018ar2026-05-05
10818674022207Suture passe110038984254001bsm2026-04-14
10810128462997Champion+ Suture Passer3910-600-001382000st2026-04-07
10810128463000Champion+ Suture Passer 3910-600-002382100st2026-04-07
10810128463024Champion+ Suture Passer 3910-600-003S382300st2026-04-07
10810128463185Hip Bone Pick 60°512404t512404t2026-03-19
10810128463192Hip 2.5 Grasper393400t393400t2026-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
108101284636284.5mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
108101284636357.0mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
108101284636428.0mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
108101284636599.0mm Can. Full Thickness DrillT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWK2026-05-13
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00190376706498InvictusALPHATEC SPINE, INC.HWK2026-04-09
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00190376706511InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706528InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706535InvictusALPHATEC SPINE, INC.HWK2026-04-09
00190376706542InvictusALPHATEC SPINE, INC.HWK2026-04-09
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