| Primary Device ID | 04046963975692 |
| NIH Device Record Key | c3f8203d-89da-4658-8830-617a74a52e51 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A-SPACE SIBD |
| Version Model Number | ME629R |
| Catalog Number | ME629R |
| Company DUNS | 315018218 |
| Company Name | Aesculap AG |
| Device Count | 1 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046963975692 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
[04046963975692]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-04 |
| Device Publish Date | 2020-04-24 |
| 04046963670207 | A-SPACE SIBD IMPLANT 9° 29X40X20MM |
| 04046963670177 | A-SPACE SIBD IMPLANT 9° 29X40X14MM |
| 04046963670122 | A-SPACE SIBD IMPLANT 4° 29X40X16MM |
| 04046963670009 | A-SPACE SIBD IMPLANT 9° 25X35X20MM |
| 04046963669904 | A-SPACE SIBD IMPLANT 4° 25X35X12MM |
| 04046963670061 | A-SPACE SIBD IMPLANT 14° 25X35X20MM |
| 04046963669928 | A-SPACE SIBD IMPLANT 4° 25X35X16MM |
| 04046963670269 | A-SPACE SIBD IMPLANT 14° 29X40X20MM |
| 04046963670252 | A-SPACE SIBD IMPLANT 14° 29X40X18MM |
| 04046963670245 | A-SPACE SIBD IMPLANT 14° 29X40X16MM |
| 04046963670238 | A-SPACE SIBD IMPLANT 14° 29X40X14MM |
| 04046963670221 | A-SPACE SIBD IMPLANT 14° 29X40X12MM |
| 04046963670214 | A-SPACE SIBD IMPLANT 14° 29X40X10MM |
| 04046963670191 | A-SPACE SIBD IMPLANT 9° 29X40X18MM |
| 04046963670184 | A-SPACE SIBD IMPLANT 9° 29X40X16MM |
| 04046963670160 | A-SPACE SIBD IMPLANT 9° 29X40X12MM |
| 04046963670153 | A-SPACE SIBD IMPLANT 9° 29X40X10MM |
| 04046963670146 | A-SPACE SIBD IMPLANT 4° 29X40X20MM |
| 04046963670139 | A-SPACE SIBD IMPLANT 4° 29X40X18MM |
| 04046963670115 | A-SPACE SIBD IMPLANT 4° 29X40X14MM |
| 04046963670108 | A-SPACE SIBD IMPLANT 4° 29X40X12MM |
| 04046963670092 | A-SPACE SIBD IMPLANT 4° 29X40X10MM |
| 04046963670054 | A-SPACE SIBD IMPLANT 14° 25X35X18MM |
| 04046963670047 | A-SPACE SIBD IMPLANT 14° 25X35X16MM |
| 04046963670030 | A-SPACE SIBD IMPLANT 14° 25X35X14MM |
| 04046963670023 | A-SPACE SIBD IMPLANT 14° 25X35X12MM |
| 04046963670016 | A-SPACE SIBD IMPLANT 14° 25X35X10MM |
| 04046963669997 | A-SPACE SIBD IMPLANT 9° 25X35X18MM |
| 04046963669980 | A-SPACE SIBD IMPLANT 9° 25X35X16MM |
| 04046963669973 | A-SPACE SIBD IMPLANT 9° 25X35X14MM |
| 04046963669966 | A-SPACE SIBD IMPLANT 9° 25X35X12MM |
| 04046963669959 | A-SPACE SIBD IMPLANT 9° 25X35X10MM |
| 04046963669942 | A-SPACE SIBD IMPLANT 4° 25X35X20MM |
| 04046963669935 | A-SPACE SIBD IMPLANT 4° 25X35X18MM |
| 04046963669911 | A-SPACE SIBD IMPLANT 4° 25X35X14MM |
| 04046963669195 | A-SPACE SIBD IMPLANT 4° 25X35X10MM |
| 04046963081539 | DISTRACTOR 20MM |
| 04046963081515 | DISTRACTOR 18MM |
| 04046963081492 | DISTRACTOR 16MM |
| 04046963081478 | DISTRACTOR 14MM |
| 04046963081454 | DISTRACTOR 12MM |
| 04046963081430 | DISTRACTOR 10MM |
| 04046964275715 | A-SPACE SIBD Bone Curette, 45 °, angled, sharp, non-sterile, reusable |
| 04046964275708 | A-SPACE SIBD Bone Curette, 60 °, reverse angled, sharp, 7,5 x 9 mm, non-sterile, reusable |
| 04046964275395 | A-SPACE SIBD Bone Curette, 60 °, reverse angled, sharp, 5,2 x 7,3 mm, non-sterile, reusable |
| 04046964275388 | A-SPACE SIBD Bone Curette, 0 °, straight, sharp, non-sterile, reusable |
| 04046963975739 | DETACHABLE WEDGE 24MM |
| 04046963975715 | DETACHABLE WEDGE 20MM |
| 04046963975708 | DETACHABLE WEDGE 18MM |
| 04046963975692 | DETACHABLE WEDGE 16MM |