FDA UDI
In Commercial Distribution
🇺🇸 United States
AMD-RITMED
DI: 10686864052712
·
Model: AFF0217
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- AMD-RITMED
- Primary DI
- 10686864052712
- Version / Model
- AFF0217
- Catalog Number
- AFF0217
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2019-01-16
- Public Version
- 3
- Public Version Date
- 2020-08-07
- Public Version Status
- Update
- Public Device Record Key
- 6c135ef8-221e-4bcc-b6f5-b41192fda925
Device Description
AMD-RITMED FABRIC ADHESIVE BANDAGES Finger Tip 1 3/4 X 2 Inch
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape and bandage, adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44990 | Skin-cover adhesive strip, non-antimicrobial | A small, narrow, flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive and possibly with an absorbent pad, typically intended to cover a superficial wound or fix a dressing to skin. It may be hypoallergenic and/or waterproof, however it does not include antimicrobial agents/properties. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20686864052719 | GS1 | Outer Case | 12 | In Commercial Distribution | |
| Primary | 10686864052712 | GS1 | ||||
| Unit of Use | 00686864052715 | GS1 |
Customer Contacts
- Phone
- +1(514)636-6262
- [email protected]
- Phone
- +1(514)636-6262 ext. 2309
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 3/4 X 2 Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool dry place