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SCANLAN® Micro Needle Holders
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 6006-35Ref 3788-13NRef 3789-14-3NRef 3003-870Ref 3789-13Ref 6006-28Ref 6006-208Ref 6006-32Ref 3003-872Ref 6006-40Ref 6006-205Ref 6006-216Ref 6006-22Ref 3003-466NRef 3789-14Ref 6006-217Ref 3788-15Ref 6006-36Ref 6006-38Ref 3789-11NRef 3003-866Ref 3788-14Ref 3003-868NRef 3788-13Ref 3788-15NRef 3788-12NRef 3789-11
Identity
- Trade Name
- SCANLAN® Micro Needle Holders FDA UDISCANLAN® Needle Holders FDA UDISCANLAN® Double Action Micro Needle Holder FDA UDISCANLAN® Instruments FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- SCANLAN® Micro Needle Holder EUDAMEDSCANLAN® Micro Needle Holder EUDAMEDSCANLAN® Double Action Micro Needle Holder EUDAMEDCurved Diamond Dust™ Jaw FDA UDIMicro Needle Holder Round Handle Bayonet Style FDA UDIMicro Needle Holder Flat Handle Bayonet Style FDA UDIMicro Needle Holder FDA UDIDiamond Dust™ jaw FDA UDILeft-Handed Diamond Dust™ Jaw FDA UDIWithout Ratchet Diamond Dust™ jaw FDA UDIWithout Ratchet Curved Diamond Dust™ jaw FDA UDIMicro Needle Holder, RH, bayo styl, w/o rat,curv 0.3mm tap DDjaws, 9"/23cm FDA UDI
- Model / Reference
- 6006-22 EUDAMEDFDA UDI3789-13 EUDAMEDFDA UDI3788-14 EUDAMEDFDA UDI3003-870 EUDAMEDFDA UDI6006-205 EUDAMEDFDA UDI6006-28 EUDAMEDFDA UDI3003-866 EUDAMEDFDA UDI6006-35 EUDAMEDFDA UDI3788-13 EUDAMEDFDA UDI3789-11 EUDAMEDFDA UDI3003-872 EUDAMEDFDA UDI3788-15 EUDAMEDFDA UDI6006-32 EUDAMEDFDA UDI3789-14 EUDAMEDFDA UDI6006-216 EUDAMEDFDA UDI6006-217 EUDAMEDFDA UDI6006-208 EUDAMEDFDA UDI3789-14-3N EUDAMEDFDA UDI6006-38 EUDAMEDFDA UDI6006-40 EUDAMEDFDA UDI6006-36 EUDAMEDFDA UDI3788-13N EUDAMED3003-466N EUDAMED3789-11N EUDAMED3003-868N EUDAMED3788-15N EUDAMED3788-12N EUDAMED
- Description
- Curved Diamond Dust™ Jaw FDA UDIMicro Needle Holder Round Handle Bayonet Style FDA UDIMicro Needle Holder Flat Handle Bayonet Style FDA UDIMicro Needle Holder FDA UDIDiamond Dust™ jaw FDA UDILeft-Handed Diamond Dust™ Jaw FDA UDIWithout Ratchet Diamond Dust™ jaw FDA UDIWithout Ratchet Curved Diamond Dust™ jaw FDA UDIMicro Needle Holder, RH, bayo styl, w/o rat,curv 0.3mm tap DDjaws, 9"/23cm FDA UDI
Identifiers
- Catalog Number
- 6006-22 FDA UDI3789-13 FDA UDI3788-14 FDA UDI3003-870 FDA UDI6006-205 FDA UDI6006-28 FDA UDI3003-866 FDA UDI6006-35 FDA UDI3788-13 FDA UDI3789-11 FDA UDI3003-872 FDA UDI3788-15 FDA UDI6006-32 FDA UDI3789-14 FDA UDI6006-216 FDA UDI6006-217 FDA UDI6006-208 FDA UDI3789-14-3N FDA UDI6006-38 FDA UDI6006-40 FDA UDI6006-36 FDA UDI
- Primary DI / UDI-DI
- 00846159020571 EUDAMEDFDA UDI00846159031706 EUDAMEDFDA UDI00846159031669 EUDAMEDFDA UDI00846159019711 EUDAMEDFDA UDI00846159020502 EUDAMEDFDA UDI00846159004472 EUDAMEDFDA UDI00846159019704 EUDAMEDFDA UDI00846159023350 EUDAMEDFDA UDI00846159031652 EUDAMEDFDA UDI00846159031683 EUDAMEDFDA UDI00846159026733 EUDAMEDFDA UDI00846159031676 EUDAMEDFDA UDI00846159004496 EUDAMEDFDA UDI00846159031713 EUDAMEDFDA UDI00846159020540 EUDAMEDFDA UDI00846159020557 EUDAMEDFDA UDI00846159020533 EUDAMEDFDA UDI00846159036312 EUDAMEDFDA UDI00846159026825 EUDAMEDFDA UDI00846159004533 EUDAMEDFDA UDI00846159004519 EUDAMEDFDA UDI00846159013290 EUDAMED00846159012316 EUDAMED00846159013405 EUDAMED00846159012873 EUDAMED00846159013313 EUDAMED00846159013283 EUDAMED
- Basic UDI-DI
- B-00846159023350 EUDAMEDB-00846159013290 EUDAMEDB-00846159036312 EUDAMEDB-00846159019711 EUDAMEDB-00846159031706 EUDAMEDB-00846159004472 EUDAMEDB-00846159020533 EUDAMEDB-00846159004496 EUDAMEDB-00846159026733 EUDAMEDB-00846159004533 EUDAMEDB-00846159020502 EUDAMEDB-00846159020540 EUDAMEDB-00846159020571 EUDAMEDB-00846159012316 EUDAMEDB-00846159031713 EUDAMEDB-00846159020557 EUDAMEDB-00846159031676 EUDAMEDB-00846159004519 EUDAMEDB-00846159026825 EUDAMEDB-00846159013405 EUDAMEDB-00846159019704 EUDAMEDB-00846159031669 EUDAMEDB-00846159012873 EUDAMEDB-00846159031652 EUDAMEDB-00846159013313 EUDAMEDB-00846159013283 EUDAMEDB-00846159031683 EUDAMED
- FDA Product Code
- FHQ FDA UDI
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4730 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Category: Suturing needle holder, reusable
SCANLAN® Micro Needle Holders by Scanlan International Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (48)
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