| Primary Device ID | 00810633020654 |
| NIH Device Record Key | 1f76eb1b-3c43-4729-a9c1-38f59943f6f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSStaple |
| Version Model Number | OS-2020W2 |
| Company DUNS | 792619009 |
| Company Name | Biomedical Enterprises, 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 | true |
| 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 | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com | |
| Phone | 210-881-0064 |
| aknight@bme-tx.com |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Width | 20 Millimeter |
| Length | 20 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810633020654 [Primary] |
| JDR | Staple, Fixation, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-05-07 |
| Device Publish Date | 2015-10-24 |
| 00810633021330 | OSStaple 30 x 30 W2 x 3 |
| 00810633021323 | OSStaple 25 x 22 W2 x 3 |
| 00810633021262 | OSStaple 20 x 15 x 15 W1.5 |
| 00810633021255 | OSStaple 18 x 25 W2 |
| 00810633021248 | OSStaple 18 x 15 x 15 mm implant 2mm diameter legs |
| 00810633021149 | OSStaple 15 x 18 W2 |
| 00810633021132 | OSStaple 15 x 18 W1.5 |
| 00810633021125 | OSStaple 15 x 15 W1.5 |
| 00810633021118 | OSStaple 15 x 12 W1.5 |
| 00810633021101 | OSStaple 13 x 10 x 10 W1.5 |
| 00810633021095 | OSStaple 11 x 19 x 17 W1.5 |
| 00810633021088 | OSStaple 11 x 17 x 15 W1.5 |
| 00810633021071 | OSStaple 11 x 15 x 13 W1.5 |
| 00810633021064 | OSStaple 11 x 08 W1.5 |
| 00810633021057 | OSSplate 15 x 10 |
| 00810633021040 | OSSplate 15 x 08 |
| 00810633021033 | OSSplate 15 x 06 |
| 00810633020661 | OSStaple 18X30W2X3 |
| 00810633020654 | OSStaple 20X20W2 |
| 00810633020647 | OSStaple 18X18X15W2 |
| 00810633020623 | OSStaple 18X25W2 |
| 00810633020609 | OSStaple 09X07W1.2 |
| 00810633020593 | OSStaple 15X15W2 |
| 00810633020586 | OSStaple 20X20 W2X3 |
| 00810633020579 | OSStaple 15X12W2 |
| 00810633020562 | OSStaple 11X10W1.5 |
| 00810633020555 | OSStaple 09X07W1.5 |
| 00810633020548 | OSStaple 07X05W1.2 |
| 00810633020395 | Step OSStaple 20X20X20 W2X3 |
| 00810633020388 | OSStaple 07X05W1.5 |