| Primary Device ID | 00192896048935 |
| NIH Device Record Key | 5b60939a-9880-4db8-9c07-623d81abad18 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GELPI SPINAL RETRACTOR |
| Version Model Number | 1100-631M |
| Catalog Number | 1100-631M |
| Company DUNS | 040729840 |
| Company Name | SONTEC INSTRUMENTS, INC. |
| 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 |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com |
| Length | 6.5 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896048935 [Primary] |
| FFO | RETRACTOR, SELF-RETAINING |
| GAD | Retractor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896048935]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-08-27 |
| Device Publish Date | 2018-09-14 |
| 00192896048935 | GELPI RETRACTOR MICRO PARALLEL BLUNT BLADES |
| 00192896038042 | GELPI SPINAL RETRACTOR WITH RATCHET DEEP ANGLED DOUBLE TIPS |
| 00192896026643 | GELPI SPINAL RETRACTOR DEEP ANGLED MULTILEVEL DISTRACTION PARALLEL TIPS |
| 00192896026605 | GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED TIP |
| 00192896026599 | GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED TIP |
| 00192896026582 | GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED TIP |
| 00192896026575 | GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED TIP |
| 00192896026568 | GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED TIP |
| 00192896026551 | GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED CEREBELLAR TIP |
| 00192896117341 | Gelpi Spinal Retractor Deep Angle Blunt Tips With Speed Lock 90 Degrees |