TSPACE FJ653R
GUDID 04038653453061
DISTRACTOR 13MM
Aesculap AG
Orthopaedic prosthesis implantation instrument, reusable| Primary Device ID | 04038653453061 |
| NIH Device Record Key | 9d0eb046-3382-4104-9de9-225efc823a6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TSPACE |
| Version Model Number | FJ653R |
| Catalog Number | FJ653R |
| 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 |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04038653453061 [Primary] |
FDA Product Code
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
[04038653453061]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-01 |
| Device Publish Date | 2020-04-23 |
On-Brand Devices [TSPACE]
| 04038653453337 | PROSPACE, TSPACE Curette, 15 °, (350 mm), straight, width: 6 mm, non-sterile, reusable |
| 04038653453238 | TSPACE TRIAL IMPLANT 12MM |
| 04038653453139 | TSPACE INSERTION GUIDE |
| 04038653453061 | DISTRACTOR 13MM |
| 04038653453054 | DISTRACTOR 12MM |
| 04038653453047 | DISTRACTOR 11MM |
| 04038653453030 | DISTRACTOR 10MM |
| 04038653453023 | DISTRACTOR 9MM |
| 04038653453016 | DISTRACTOR 8MM |
| 04038653452996 | T-HANDLE F/DISTRACTORS/TRIAL IMPLANTS |
| 04046963834951 | TSPACE PEEK IMPACTOR |
| 04046963834920 | TSPACE PEEK INSERTER W/OFFSET HANDLE |
| 04038653453078 | DISTRACTOR 14MM |
| 04038653471102 | TSPACE PEEK TRAY IMPLANTATION INSTR. |
| 04038653471096 | TSPACE PEEK TRAY PREPARATION INSTR. |
| 04038653453276 | TSPACE TRIAL IMPLANT 16MM |
| 04038653453252 | TSPACE TRIAL IMPLANT 14MM |
| 04038653453092 | DISTRACTOR 16MM |
| 04038653453160 | TSPACE PEEK PACKING BLOCK |
| 04038653453122 | TSPACE PEEK INSERTION INSTRUMENT |
| 04038653453153 | TSPACE IMPACTOR ANGLED |
| 04038653453146 | TSPACE IMPACTOR STR |
| 04038653453382 | TSPACE BONE RASP 45°RT.ANG 10/350MM |
| 04038653453375 | TSPACE BONE RASP 45°LT.ANG 10/350MM |
| 04038653453351 | TSPACE Curette, 45 °, (350 mm), width: 6,500 mm, non-sterile, reusable |
| 04038653453344 | TSPACE Curette, 45 °, (350 mm), width: 6,500 mm, non-sterile, reusable |
| 04038653453313 | TSPACE Bone Curette, 45 °, (350 mm), width: 6,300 mm, non-sterile, reusable |
| 04038653453306 | TSPACE Bone Curette, 45 °, (350 mm), width: 6,300 mm, non-sterile, reusable |
| 04038653453177 | INSERTION/EXTRACTION INSTR.(SLAP HAMMER) |
| 04046963834968 | TSPACE PEEK PACKING BLOCK |
| 04046963834944 | TSPACE PEEK INSERTION INSTRUMENT CVD |
| 04046963834937 | TSPACE PEEK INSERTION INSTRUMENT STR |
| 04038653453283 | TSPACE TRIAL IMPLANT 17MM |
| 04038653453269 | TSPACE TRIAL IMPLANT 15MM |
| 04038653453245 | TSPACE TRIAL IMPLANT 13MM |
| 04038653453221 | TSPACE TRIAL IMPLANT 11MM |
| 04038653453214 | TSPACE TRIAL IMPLANT 10MM |
| 04038653453207 | TSPACE TRIAL IMPLANT 9MM |
| 04038653453191 | TSPACE TRIAL IMPLANT 8MM |
| 04038653453184 | TSPACE TRIAL IMPLANT 7MM |
| 04038653453115 | TSPACE/PROSPACE OSTEOTOME 8/300MM |
| 04038653453108 | DISTRACTOR 17MM |
| 04038653453085 | DISTRACTOR 15MM |
| 04038653453009 | DISTRACTOR 7MM |
Trademark Results [TSPACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TSPACE 79024410 3256683 Live/Registered |
Aesculap AG 2006-03-20 |
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