FDA.report

Surgical Direct

Primary DI
B382SD8031S0
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD8031s
Catalog number
SD8031s
Device description
Mister Clear fog reduction, Sterile, Single use, 1 units, Sample
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B382SD8031S0PrimaryHIBCC0

GMDN Terms

TermDefinition
Endoscope antifog sheathA tubular sleeve designed to encompass an endoscope to direct the flow of carbon dioxide (CO2) insufflation gas to the distal end of the endoscope to prevent condensation and maintain a clear image of the intervention site. It is introduced through an endoscopic access trocar/cannula and involves switching the gas supply from the trocar/cannula to this sleeve. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags

DUNS number
124367223
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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B382S9057001000Surgical DirectS905700.100S905700.1002026-03-09
B382SD18129DK0Surgical DirectSD18129DKSD18129DK2026-03-09
B382SD40060510052E00Surgical DirectSD40060-51005-2ESD40060-51005-2E2026-03-09
B382SD4387110Surgical DirectSD4387-11SD4387-112026-03-09
B382SD481753PTSTR0Surgical DirectSD48-1753PT-STRSD48-1753PT-STR2026-03-09

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