FDA.reportPublic FDA data

Pilling

Primary DI
00190776024703
Brand
Pilling
Company
Avalign Technologies, Inc.
Model
168255
Device description
Oval Ring Retractor Large
Published
2017-03-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776024703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776024703001907760247031907760247030190776024703

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system mounting frame, reusableA noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18.5Inch
Width12Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705034577241N/AMedos International SàrlGZT2026-03-20
10705034577258N/AMedos International SàrlGZT2026-03-20
10705034577265N/AMedos International SàrlGZT2026-03-20
00810123209736Adler Instrument CompanyAdler, Inc.GZT2026-01-02
00840343726454GEN2SURGIX MEDICAL LLCGZT2025-06-09
00810123209057Adler Instrument CompanyAdler, Inc.GZT2025-04-09
00810123208814Adler Instrument CompanyAdler, Inc.GZT2025-03-19
00810123208852Adler Instrument CompanyAdler, Inc.GZT2025-03-19
00810123208869Adler Instrument CompanyAdler, Inc.GZT2025-03-19
00810123208876Adler Instrument CompanyAdler, Inc.GZT2025-03-19
00840343723439GEN2SURGIX MEDICAL LLCGZT2024-09-18
00840343723712GEN2SURGIX MEDICAL LLCGZT2024-09-13
04046826464851MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGZT2024-09-09
04046826464868MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGZT2024-09-09
04046826464875MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGZT2024-09-09
04046826464882MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGZT2024-09-09
00887482157114Symmetry McCullochASPEN SURGICAL PRODUCTS, INC.GZT2024-08-14
00887482045305Symmetry Markham-MeyerdingASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482056462Symmetry FergusonASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482104545Symmetry Ultra™ RevealASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482104866Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482104873Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105061Symmetry Ultra® RevealASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105245Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105252Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105269Symmetry Ultra™ RevealASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105276Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105306Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105313Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07
00887482105320Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GZT2024-08-07