Flexible Guide Pin (Stryker ACL Versitomic)

FDA UDIEUDAMED

Class I (US FDA UDI)

by T.a.g Medical Products Agricultural Cooperative Association

Identity

Trade Name: Flexible Guide Pin (Stryker ACL Versitomic) FDA UDI
Generic Name: Surgical drill guide, single-use FDA UDI
Model / Reference: E FDA UDI

Identifiers

Catalog Number: tg108020st FDA UDI
Primary DI / UDI-DI: 10810190016029 FDA UDI
FDA Product Code: HWK FDA UDI
GMDN Term: Surgical drill guide, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide, single-use

Flexible Guide Pin (Stryker ACL Versitomic) by T.a.g Medical Products Agricultural Cooperative Association — Class I — MDR, FDA UDI — listed in FDA GUDID…

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: T.a.g Medical Products Agricultural Cooperative Association

Sources (2)

FDA UDI 3fc55a3c-684e-4da2-912d-c2e7e746f6ab 33 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 3, 2026