FDA.reportPublic FDA data

Zinnanti Surgical

Primary DI
G3731331500
Brand
Zinnanti Surgical
Company
Zinnanti Surgical Design Group Inc
Model
13-3150
Device description
Derm Adapter Sleeve 12" Non-Sterile
Published
2026-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G3731331500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Regulatory Flags#

DUNS number
078579514
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G373ZS250Zinnanti Surgical ZS252026-04-09
G373ZSE250Zinnanti SurgicalZSE252026-04-09
G3731433010Zinnanti Surgical14-33012026-03-04
G373131023DB0Zinnanti Surgical13-1023DB2026-01-27
G373131023DS0Zinnanti Surgical13-1023DS2026-01-27
G373Z13000Zinnanti SurgicalZ-13002026-01-15
G373144010HB0Zinnanti Surgical14-4010-HB2025-07-29
G3731431000Zinnanti Surgical14-31002025-06-30
G3731431500Zinnanti Surgical14-31502025-06-30
G373DM00300Diagnostic MedicalDM00302025-02-25
G373DM25100Diagnostic MedicalDM25102025-02-25
G373DS10080Diagnostic MedicalDS10082025-02-25
G373144051ESU0Zinnanti Surgical14-4051ESU2024-12-11
G3731440140Zinnanti Surgical14-40142024-10-09
G373144051DHB0Zinnanti Surgical14-4051DHB2024-09-13
G373144005J0Zinnanti Surgical14-4005J2024-08-27
G3731440150Zinnanti Surgical14-40152024-08-23
G373144017HB0Zinnanti Surgical 14-4017HB2024-08-23
G3731401100Zinnanti Surgical14-01102024-08-14
G3731401150Zinnanti Surgical14-01152024-08-14

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Primary DI, Brand, Company table
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