FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Welch Allyn, Inc.
DI: 00732094073065
·
Model: 901069
·
WELCH ALLYN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Welch Allyn, Inc.
- Primary DI
- 00732094073065
- Version / Model
- 901069
- Catalog Number
- 46074
- Company Name
- WELCH ALLYN, INC.
- Labeler DUNS
- 198227881
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 6
- Public Version Date
- 2021-05-31
- Public Version Status
- Update
- Public Device Record Key
- 8cb3c2d5-aed0-4be9-a794-43be8b6d8d12
- Distribution End Date
- 2021-05-28
Device Description
Welch Allyn Green Series LED Portable Headlight; One White LED, 40 Lumens, 5,500° K; Soft Terrycloth Headband; 230 V, 50-60 Hz AC, Rechargeable (#72270) Battery; IEC Plug Type-G
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FSR | Light, headband, surgical | Ophthalmic | 886.4335 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36843 | Mobile examination/treatment room light | A mobile device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s), which reflect the light via reflectors or mirrors depending upon the construction, and will often be mounted on a pantograph counterbalance assembly that is attached to a mobile mount. It is usually used during examination or treatment in locations that do not have the required lighting installed. This device is designed to be easily moved from one location to another. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00732094073065 | GS1 |
Customer Contacts
- Phone
- +1(315)685-2834
- [email protected]