Identity
- Trade Name
- AESCULAP FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- HOESEL DUROGRIP TC Needleholder, straight, 10 1/4", (260 mm), bayonet-shaped, with 0.5 mm pitch of serration, Mathieu type handle, Mathieu type ratchet, suture up to 3/0, non-sterile, reusable FDA UDI
- Model / Reference
- BM168R FDA UDI
- Description
- HOESEL DUROGRIP TC Needleholder, straight, 10 1/4", (260 mm), bayonet-shaped, with 0.5 mm pitch of serration, Mathieu type handle, Mathieu type ratchet, suture up to 3/0, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- BM168R FDA UDI
- Primary DI / UDI-DI
- 04038653139712 FDA UDI
- FDA Product Code
- HXK FDA UDI
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Aesculap by Aesculap, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap, Inc.
Sources (1)
- FDA UDI 75939903-50a2-40d5-86d2-363ae4629a2f 36 fields · synced Jun 8, 2026