FDA UDI
In Commercial Distribution
🇺🇸 United States
Chest Depth Caliper
DI: 00855170007232
·
Model: 01140
·
LAFAYETTE INSTRUMENT COMPANY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Chest Depth Caliper
- Primary DI
- 00855170007232
- Version / Model
- 01140
- Catalog Number
- 01140
- Company Name
- LAFAYETTE INSTRUMENT COMPANY, INC.
- Labeler DUNS
- 005080650
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-31
- Public Version
- 2
- Public Version Date
- 2023-06-14
- Public Version Status
- Update
- Public Device Record Key
- a2fc722b-1844-426c-b226-fd26a15d3402
Device Description
The Chest Depth Caliper accurately measures chest depth in inches or centimeters. Popular uses include measuring maximum chest expansion from resting to full inspiration. Range is from 0 to 24 inches in 0.50 inch graduations (0 to 60 cm with 2.0 cm graduations).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KTZ | Caliper | Orthopedic | 888.4150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48167 | General-purpose calliper, plastic | A non-sterile, manually-operated, lubricant free, plastic device with an analogue Vernier scale designed to make accurate measurements of a patient's anatomy, or of other objects, during surgery, autopsy, or in other clinical settings. It is intended to make external measurements (e.g., external diameter, thickness), internal measurements (e.g., internal diameter, depth), measure length, or make step measurements (i.e., from a larger edge to a lesser edge on an object). It is typically made of reinforced plastic that cannot be steam sterilized. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855170007232 | GS1 |
Customer Contacts
- Phone
- 765-423-1505
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 40 – 95 Degrees Fahrenheit