Primary Device ID | 00814703015298 |
NIH Device Record Key | 500787fd-806f-445c-969f-2912176aa221 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Klassic HD Hooded Acetabular Insert with XLPE Poly |
Version Model Number | 3508.48.032 |
Company DUNS | 078416717 |
Company Name | TOTAL JOINT ORTHOPEDICS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | true |
OTC Over-The-Counter | false |
Phone | +1(801)486-6070 |
udi@tjoinc.com | |
Phone | +1(801)486-6070 |
udi@tjoinc.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00814703015298 [Primary] |
OQG | Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00814703015298]
Ethylene Oxide
[00814703015298]
Ethylene Oxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-07-13 |
Device Publish Date | 2018-06-12 |
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00814703015410 | Hooded Acetabular Insert with XLPE Poly, 36mm head, size 58mm |
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00814703015373 | Hooded Acetabular Insert with XLPE Poly, 32mm head, size 64mm |
00814703015366 | Hooded Acetabular Insert with XLPE Poly, 32mm head, size 62mm |
00814703015359 | Hooded Acetabular Insert with XLPE Poly, 32mm head, size 60mm |
00814703015342 | Hooded Acetabular Insert with XLPE Poly, 32mm head, size 58mm |
00814703015335 | Hooded Acetabular Insert with XLPE Poly, 32mm head, size 56mm |
00814703015328 | Hooded Acetabular Insert with XLPE Poly, 32mm head, size 54mm |
00814703015311 | Hooded Acetabular Insert with XLPE Poly, 32mm head, size 52mm |
00814703015304 | Hooded Acetabular Insert with XLPE Poly, 32mm head, size 50mm |
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00814703015281 | Hooded Acetabular Insert with XLPE Poly, 28mm head, size 46mm |
00814703015274 | Hooded Acetabular Insert with XLPE Poly, 28mm head, size 44mm |
00814703015267 | Hooded Acetabular Insert with XLPE Poly, 22mm head, size 46mm |
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