Identity
- Trade Name
- NL 100 Breast Marker FDA UDI
- Generic Name
- Skin marking guide, single-use FDA UDI
- Device Name
- NL 100 Breast Marker is used to assist in nipple placement during breast reconstructive surgery. A temporary impression is made by pressing the marker onto skin with a gentle rotating motion. Methylene blue may be used as a marking agent. The NL 100 Breast Marker provides two marking edges: 42 mm and 38 mm. FDA UDI
- Model / Reference
- NL 100 FDA UDI
- Description
- NL 100 Breast Marker is used to assist in nipple placement during breast reconstructive surgery. A temporary impression is made by pressing the marker onto skin with a gentle rotating motion. Methylene blue may be used as a marking agent. The NL 100 Breast Marker provides two marking edges: 42 mm and 38 mm. FDA UDI
Identifiers
- Catalog Number
- NL 100 FDA UDI
- Primary DI / UDI-DI
- M996NL1000 FDA UDI
- FDA Product Code
- FTY FDA UDI
- GMDN Term
- Skin marking guide, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Category: Skin marking guide, single-use
NL 100 Breast Marker by Instrumentation Industries, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Instrumentation Industries, Incorporated
Sources (1)
- FDA UDI 7bed0428-56d5-434b-b1aa-310e42af44b9 35 fields · synced Jun 7, 2026