FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Welch Allyn, Inc.
DI: 00732094016659
·
Model: 901026
·
WELCH ALLYN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Welch Allyn, Inc.
- Primary DI
- 00732094016659
- Version / Model
- 901026
- Catalog Number
- 18320-PSM
- Company Name
- WELCH ALLYN, INC.
- Labeler DUNS
- 198227881
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 4
- Public Version Date
- 2021-05-10
- Public Version Status
- Update
- Public Device Record Key
- ae881765-0637-450d-b1d2-b8fa716287aa
- Distribution End Date
- 2019-04-04
Device Description
Welch Allyn 3.5 V Halogen HPX Ophthalmic Set including PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (# 11820), Elite Streak Retinoscope (#18240), Rechargeable 120-Minute Power Handle(s), Hard Storage Case, Fixation Cards, C-Cell Battery Converter Accessory; Lithium-Ion (#71960) Battery; IEC Plug Type-A
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
- Yes
- 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 |
|---|---|---|---|---|
| ERA | OTOSCOPE | Ear, Nose, Throat | 874.4770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12849 | Otoscope, direct | An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00732094016659 | GS1 |
Customer Contacts
- Phone
- +1(315)685-2834
- [email protected]