| Primary Device ID | G422DL3010 |
| NIH Device Record Key | d1a904f0-09c6-4fa4-9ab8-b4bd270b456e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HANK DILATOR SET OF 6 (Z304) |
| Version Model Number | DL301 |
| Catalog Number | DL301 |
| Company DUNS | 645680898 |
| Company Name | BIOPSY FINE CUT INSTRUMENTS |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G422DL3010 [Primary] |
| KCF | Dilator, Esophageal, Ent |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
[G422DL3010]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-23 |
| Device Publish Date | 2023-10-13 |
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| G422SP0030 - GRAVES VAG SPEC LG 4.5 | 2024-10-11 |
| G422BP0120 - TISCHLER KEVORKIAN BIOPSY PUNCH | 2023-12-06 TISCHLER KEVORKIAN BIOPSY PUNCH 8.25" |
| G422BP0181 - TISCHLER MORGAN BIOPSY PUNCH 10" | 2023-10-23 Size 10" Straight Made by stainless steel |
| G422BP0191 - BABY TISCHLER BIOPSY PUNCH 10" | 2023-10-23 Size 10" Made by Stainless Steel |
| G422BP1091 - ROTO TISCHLER BIOPSY PUNCH 10" | 2023-10-23 ROTO TISCHLER BIOPSY PUNCH 10" UP, COMPLETE SET HANDLE+TIP |
| G422DL0030 - MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MM | 2023-10-23 MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MM |
| G422DL1010 - DILATOR CERVICAL SET OF 6 | 2023-10-23 DILATOR CERVICAL SET OF 6, (1-6MM) |