FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Zip 16 Surgical Skin Closure Device
DI: 00853114007119
·
Model: PS1160
·
ZIPLINE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Zip 16 Surgical Skin Closure Device
- Primary DI
- 00853114007119
- Version / Model
- PS1160
- Catalog Number
- PS1160
- Company Name
- ZIPLINE MEDICAL, INC.
- Labeler DUNS
- 962534124
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-02
- Public Version
- 4
- Public Version Date
- 2021-02-01
- Public Version Status
- Update
- Public Device Record Key
- 793029f0-783c-4304-9176-89cc877fa768
- Distribution End Date
- 2019-12-12
Device Description
Zip 16 Surgical Skin Closure Device, PSA
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|
| 34864 | Adhesive bandage | A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10853114007116 | GS1 | Zip®16, 10-pack | 10 | Not in Commercial Distribution | 2019-03-15 |
| Primary | 00853114007119 | GS1 |
Customer Contacts
- Phone
- 888-326-8999
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 16 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight and heat. Keep Dry