FDA.reportPublic FDA data

Zinnanti Surgical

Primary DI
G3731431500
Brand
Zinnanti Surgical
Company
Zinnanti Surgical Design Group Inc
Model
14-3150
Device description
"Derm Adapter Sleeve 12"" Sterile"
Published
2025-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
G3731431500PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078579514
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G3731331500Zinnanti Surgical13-31502026-06-10
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756401753DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401760DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401777DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401784DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00850078013101MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013118MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013125MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013132MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013149MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00840456224571JMUJMU DENTAL, INCLYU2026-08-18
00840456224588JMUJMU DENTAL, INCLYU2026-08-18
00840456224595JMUJMU DENTAL, INCLYU2026-08-18
00840456224601JMUJMU DENTAL, INCLYU2026-08-18
00840456224618JMUJMU DENTAL, INCLYU2026-08-18
00840456218402JMUJMU DENTAL, INCLYU2026-07-06
00840456218419JMUJMU DENTAL, INCLYU2026-07-06
00840456218426JMUJMU DENTAL, INCLYU2026-07-06
00840456218433JMUJMU DENTAL, INCLYU2026-07-06
00840456218440JMUJMU DENTAL, INCLYU2026-07-06
00840456218457JMUJMU DENTAL, INCLYU2026-07-06
00840456218464JMUJMU DENTAL, INCLYU2026-07-06
00840456218471JMUJMU DENTAL, INCLYU2026-07-06
00840456218488JMUJMU DENTAL, INCLYU2026-07-06
00840456218495JMUJMU DENTAL, INCLYU2026-07-06
00840456220894JMUJMU DENTAL, INCLYU2026-07-06
00840456220900JMUJMU DENTAL, INCLYU2026-07-06
00840456220917JMUJMU DENTAL, INCLYU2026-07-06
00840456220924JMUJMU DENTAL, INCLYU2026-07-06
00840456220931JMUJMU DENTAL, INCLYU2026-07-06
00840456220948JMUJMU DENTAL, INCLYU2026-07-06