RLZB32DGT

GUDID 20705036011696

GASTRIC BAND KIT

Obtech Medical Sàrl

Gastric band
Primary Device ID20705036011696
NIH Device Record Key8f0912d7-7342-4853-ab9b-de425e98d48a
Commercial Distribution Discontinuation2018-02-06
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberRLZB32DGT
Catalog NumberRLZB32DGT
Company DUNS486911852
Company NameObtech Medical Sàrl
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS120705036011696 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-09-17

Devices Manufactured by Obtech Medical Sàrl

30705036003964 - N/A2020-04-14 Gastric Band Dissector
30705036003971 - N/A2020-04-14 Gastric Calibration Tube
30705036003988 - N/A2020-04-14 Gastric Calibration Tube
30705036004015 - NA2020-04-14 Gastric Band Sutureless Port and Applier
30705036004008 - NA2019-11-07 Curved Adjustable Gastric Band with Sutureless Port and Applier
20705036011665 - NA2018-03-29 GASTRIC BAND KIT
20705036011672 - NA2018-03-29 GASTRIC BAND KIT
20705036011689 - NA2018-03-29 GASTRIC BAND KIT

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