Primary Device ID | 00817602020905 |
NIH Device Record Key | a013a8a5-fad8-4b55-97a2-69a2ceff5b5d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | C-Core 19155 LAVH Drape |
Version Model Number | 19155 |
Catalog Number | 19155 |
Company DUNS | 014464314 |
Company Name | EXACT MEDICAL MANUFACTURING, 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 | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 716-681-0866 |
rdean@exactmm.com | |
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rdean@exactmm.com | |
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Phone | 716-681-0866 |
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Phone | 716-681-0866 |
rdean@exactmm.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817602020899 [Primary] |
GS1 | 00817602020905 [Package] Contains: 00817602020899 Package: Case [15 Units] In Commercial Distribution |
KKX | Drape, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-11-08 |
Device Publish Date | 2016-09-26 |
26975424195848 - Exact Medical Manufacturing, Inc. | 2025-04-03 Incise Drape, 16x19cm, Adhesive Area 10x19cm |
26975424195855 - Exact Medical Manufacturing, Inc. | 2025-04-03 Incise Drape 45cm x 55cm - 18" x 22" |
26975424195862 - Exact Medical Manufacturing, Inc. | 2025-04-03 Fenestrated Drape with Linear Tear Technology - 89x127cm |
26975424195879 - Exact Medical Manufacturing, Inc. | 2025-04-03 Ophthalmic Full Body Drape 183cm x 292cm - 72" x 115" |
26975424195886 - Exact Medical Manufacturing, Inc. | 2025-04-03 Two-Tier Backtable Cover HD 183cm - 72" |
16975424195940 - Exact Medical Manufacturing, Inc. | 2025-04-03 Ivoclar Cover with Elastic bands, folded |
16975424195964 - Exact Medical Manufacturing, Inc. | 2025-04-03 Probe Cover, PE,Tape tip,Gel & Elastic bands 18x28cm-7"x11" |
16975424195971 - Exact Medical Manufacturing, Inc. | 2025-04-03 Probe Cover (Flat End) W/Gel & Bands 5.5" x 48" |