Primary Device ID | E2995001S9 |
NIH Device Record Key | 0b0c5fca-7d16-4bd5-b3c4-6abaf418a96a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | wood wedges |
Version Model Number | 5001s |
Catalog Number | 5001s |
Company DUNS | 481461598 |
Company Name | Polydentia SA |
Device Count | 100 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | E2995001S0 [Primary] |
HIBCC | E2995001S9 [Unit of Use] |
DZN | Instruments, Dental Hand |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-31 |
Device Publish Date | 2023-08-23 |
E29950600 | assorted (XS, S, M, L) 600 pcs |
E29950400 | assorted (XS, S, M, L) 400 pcs |
E29950179 | 17 mm (XL), 100 pcs. |
E29950159 | 15 mm (L), 100 pcs. |
E29950139 | 13 mm (M), 100 pcs. |
E29950129 | 12 mm (S), 100 pcs. |
E29950010 | assorted (XS, S, M, L) 100 pcs. |
E2995017PLUS9 | 17 mm (XL) 1000 pcs. |
E2995015PLUS9 | 15 mm (L) 1000 pcs. |
E2995013PLUS9 | 13 mm (M) 1000 pcs. |
E2995012PLUS9 | 12 mm (S) 1000 pcs. |
E2995001S9 | assorted 100 pcs. |
E2995001PLUS9 | assorted (XS, S, M ,L) 1000 pcs. |