FDA.reportPublic FDA data

NAPA Access System

Primary DI
10888857596801
Brand
NAPA Access System
Company
VB Spine LLC
Model
8030-10028
Catalog number
8030-10028
Device description
8030-10028
Published
2026-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857596801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885759680110888857596801

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(571)919-2000alex.lopez@vbspineco.com

Regulatory Flags#

DUNS number
119508156
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888857578951Q Interbody Instruments8020-900168020-900162026-03-03
10888857579866Q Interbody Instruments8020-900158020-900152026-03-03
10888857579880Q Interbody Instruments8020-900148020-900142026-03-03
10888857599710YUKON OCT Spinal SystemPRO-1435PRO-14352026-08-25
10888857556072CASCADIA Interbody System8030-900328030-900322024-01-04
10888857557260CASCADIA Interbody System8030-900008030-900002024-01-04
10888857557277CASCADIA Interbody System8030-900018030-900012024-01-04
10888857383746CASCADIA™ Interbody System7902-900387902-900382021-01-29
10888857383753CASCADIA™ Interbody System7902-900397902-900392021-01-29
10888857383814CASCADIA™ Interbody System7902-900457902-900452021-01-29
10888857313354VIKOS® Allograft System2504-900592504-900592020-01-08
10888857326408VIKOS® Allograft System2504-900572504-900572020-01-08
10888857596740NAPA Access System8030-100228030-100222026-07-31
10888857596757NAPA Access System8030-100238030-100232026-07-31
10888857596764NAPA Access System8030-100248030-100242026-07-31
10888857596771NAPA Access System8030-100258030-100252026-07-31
10888857596788NAPA Access System8030-100268030-100262026-07-31
10888857596795NAPA Access System8030-100278030-100272026-07-31
10888857596818NAPA Access System8030-100298030-100292026-07-31
10888857596825NAPA Access System8030-100308030-100302026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221370884TRYPTIK® TiSpineArt SAFSM2026-08-27
07613327630602MakoMAKO SURGICAL CORP.FSM2026-08-25
00724995296216V. MuellerSteris CorporationFSM2026-08-21
00724995296223V. MuellerSteris CorporationFSM2026-08-21
00724995296230V. MuellerSteris CorporationFSM2026-08-21
00724995296247V. MuellerSteris CorporationFSM2026-08-21
00724995296254V. MuellerSteris CorporationFSM2026-08-21
00724995296261V. MuellerSteris CorporationFSM2026-08-21
00724995296278V. MuellerSteris CorporationFSM2026-08-21
00724995296285V. MuellerSteris CorporationFSM2026-08-21
00724995296292V. MuellerSteris CorporationFSM2026-08-21
00724995296308V. MuellerSteris CorporationFSM2026-08-21
00724995296315V. MuellerSteris CorporationFSM2026-08-21
00724995296322V. MuellerSteris CorporationFSM2026-08-21
00724995296339V. MuellerSteris CorporationFSM2026-08-21
00724995296346V. MuellerSteris CorporationFSM2026-08-21
00724995296353V. MuellerSteris CorporationFSM2026-08-21
00724995296360V. MuellerSteris CorporationFSM2026-08-21
00724995296377V. MuellerSteris CorporationFSM2026-08-21
00724995296384V. MuellerSteris CorporationFSM2026-08-21
00724995296391V. MuellerSteris CorporationFSM2026-08-21
00724995296407V. MuellerSteris CorporationFSM2026-08-21
00724995296414V. MuellerSteris CorporationFSM2026-08-21
00724995296421V. MuellerSteris CorporationFSM2026-08-21
00724995296438V. MuellerSteris CorporationFSM2026-08-21
00724995296445V. MuellerSteris CorporationFSM2026-08-21
00724995296452V. MuellerSteris CorporationFSM2026-08-21
00724995296469V. MuellerSteris CorporationFSM2026-08-21
00724995296476V. MuellerSteris CorporationFSM2026-08-21
00724995296483V. MuellerSteris CorporationFSM2026-08-21