| Primary Device ID | 00842102112515 | 
| NIH Device Record Key | 9b832592-33e6-4495-9727-c65e366d9a76 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Bookler Table Mounted Retractor Systems | 
| Version Model Number | 69081 | 
| Company DUNS | 047644935 | 
| Company Name | FLEXBAR MACHINE CORPORATION | 
| 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 | false | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| 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 | 
|---|---|
| GS1 | 00842102112515 [Primary] | 
| FFO | Retractor, Self-Retaining | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
[00842102112515]
Moist Heat or Steam Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2019-03-11 | 
| Device Publish Date | 2019-01-31 | 
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| 00842102107344 | Ring, Round Small, 8 1/2" (21.6cm) Diameter | 
| 00842102107337 | Ring, Round, Large, 12 1/2 (31.8cm) Diameter | 
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| 00842102107313 | Ring, Segmented, Small, 8 1/2 x 14" (21.6 x 35.6 cm) | 
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