← Back to catalogue

Panacryl

FDA UDI

Class II (US FDA UDI)

by DePuy Mitek, Inc.

Identity

Trade Name
PANACRYL FDA UDI
Generic Name
Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name
Rotator Cuff EasyAnchor with PANACRYL Size 2 (5 metric) PANACRYL braided absorbable suture, 36 Inches (91 cm), double-armed with CP-2 needles on disposable inserter FDA UDI
Model / Reference
212731 FDA UDI
Description
Rotator Cuff EasyAnchor with PANACRYL Size 2 (5 metric) PANACRYL braided absorbable suture, 36 Inches (91 cm), double-armed with CP-2 needles on disposable inserter FDA UDI

Identifiers

Catalog Number
212731 FDA UDI
Primary DI / UDI-DI
10886705002177 FDA UDI
510(k) Number
K915889 FDA UDI
K992611 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Tendon/ligament bone anchor, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Panacryl by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
DePuy Mitek, Inc.

Sources (1)

  • FDA UDI 9ec3d210-380c-407a-82e7-46a1ad84a47f 38 fields · synced May 30, 2026