FDA UDI
In Commercial Distribution
🇺🇸 United States
AMD-RITMED
DI: 10686864052583
·
Model: A9004
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- AMD-RITMED
- Primary DI
- 10686864052583
- Version / Model
- A9004
- Catalog Number
- A9004
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2019-01-13
- Public Version
- 1
- Public Version Date
- 2019-02-13
- Public Version Status
- New
- Public Device Record Key
- 241e6d9c-fe72-44b3-bb99-6367c41eaab4
Device Description
AMD-RITMED SURGICAL HOOD Universal
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| FYF | CAP, SURGICAL | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43315 | Surgical hood | A non-sterile head covering designed as a top with elongated sides and back with a front opening for the face to be used by surgical staff to cover their hair and facial hair (beards) in order to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is typically made of soft, disposable materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20686864052580 | GS1 | Outer Case | 5 | In Commercial Distribution | |
| Primary | 10686864052583 | GS1 | ||||
| Unit of Use | 00686864052586 | GS1 |
Customer Contacts
- Phone
- +1(514)636-6262 ext. 2309
- [email protected]
- Phone
- +1(514)636-6262
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Universal |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool dry place