FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Drape
DI: 04250676737984
·
Model: 56103
·
Spiggle & Theis Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Disposable Drape
- Primary DI
- 04250676737984
- Version / Model
- 56103
- Company Name
- Spiggle & Theis Medizintechnik GmbH
- Labeler DUNS
- 332893028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-03-12
- Public Version
- 1
- Public Version Date
- 2020-03-20
- Public Version Status
- New
- Public Device Record Key
- 3f73c42c-8395-4df6-b051-c0668eb5eff4
Device Description
Disposable Drape, for Cirq® Robotic, 165 x 26 cm, 5 pcs / box
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 14250676737981 | GS1 | ||||
| Primary | 04250676737984 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 165 | Centimeter | |
| Width | 26 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 77 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 80 Percent (%) Relative Humidity