Welch Allyn, Inc.
- Primary DI
- 00732094088489
- Brand
- Welch Allyn, Inc.
- Company
- WELCH ALLYN, INC.
- Model
- 901080
- Catalog number
- 12860
- Device description
- Klinic Pkt. 2.5 V Ophthalmoscope and Handle
- Published
- 2019-09-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ERA | Otoscope | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00732094088489 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00732094088489 | 00732094088489 | 732094088489 | 0732094088489 |
GMDN Terms
| Term | Definition |
|---|
| Direct ophthalmoscope, battery-powered | A battery-powered, hand-held, ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media (cornea, aqueous, lens, and vitreous). It consists of a built-in light source that is directed by the examiner through the pupil to illuminate the interior of the eyeball, a mirror with a single view hole, and a dial containing several lenses of different powers that can be alternated by the examiner while viewing. It produces an upright, or unreversed, image of about 15 times magnification. Batteries are housed in the instrument’s handle; supplemental devices (e.g., spare light bulbs) may be included. |
Regulatory Flags
- DUNS number
- 198227881
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00732094055245 | Welch Allyn, Inc. | 901001 | SM2551 | 2026-03-06 |
| 00887761976283 | Life2000 | MS-01-0125 | | 2026-02-09 |
| 00887761978041 | Life2000 | MS-01-0121 | | 2026-02-09 |
| 00732094360363 | Welch Allyn, Inc. | 901144 | QS-6AA-AEAAA | 2026-02-03 |
| 00732094360370 | Welch Allyn, Inc. | 901144 | XSCRIBE-6AA-ACAAA | 2026-02-03 |
| 00732094360295 | Welch Allyn, Inc. | 901204 v7.4.2 | E10001 | 2025-12-18 |
| 00732094357929 | Welch Allyn, Inc. | 901026 | 71-XM2LXE | 2025-11-25 |
| 00732094358933 | Welch Allyn, Inc. | 901203 | C360KIT95RXTBWLJBP | 2025-11-24 |
| 00732094358957 | Welch Allyn, Inc. | 901203 | C360KIT95MXTBWLJBP | 2025-11-24 |
| 00732094358971 | Welch Allyn, Inc. | 901203 | C360KIT95CXTBWLJBP | 2025-11-24 |
| 00732094358988 | Welch Allyn, Inc. | 901203 | C360KIT95CXTBMBJX | 2025-11-24 |
| 00732094237740 | Welch Allyn, Inc. | 901049 | CP150A | 2025-09-22 |
| 00732094356366 | Welch Allyn, Inc. | 901006 | 9293-046-57 | 2025-09-22 |
| 00732094356373 | Welch Allyn, Inc. | 901006 | 9293-046-55 | 2025-09-22 |
| 00732094356380 | Welch Allyn, Inc. | 901006 | 9293-046-06 | 2025-09-22 |
| 00732094356397 | Welch Allyn, Inc. | 901006 | 9293-046-05 | 2025-09-22 |
| 00732094356403 | Welch Allyn, Inc. | 901006 | 9293-046-04 | 2025-09-22 |
| 00732094356410 | Welch Allyn, Inc. | 901006 | 9293-046-03 | 2025-09-22 |
| 00732094309225 | Welch Allyn, Inc. | 901057 | 44XT | 2021-04-26 |
| 06932825304237 | Welch Allyn, Inc. | 901123 | 2000 PLUS-A | 2025-08-08 |
Other Devices Sharing Product Codes
myhillrom.onmicrosoft.com