FDA.reportPublic FDA data

NS30800 Suture Bag 400 each/case

Primary DI
20787551013294
Brand
NS30800 Suture Bag 400 each/case
Company
XODUS MEDICAL, INC.
Model
NS30800
Catalog number
NS30800
Device description
NS30800 Suture Bag 400 each/case
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20787551013294PackageGS1400In Commercial Distribution
00787551013290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755101329420787551013294
00787551013290007875510132907875510132900787551013290

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument interim-placement holder, single-useA device intended to be used in the operating room (OR) by staff to safely hold a hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors, robotic system instrument hand-held remote controller] when not in use during surgery, to avoid damage to the instrument, maintain its sterility, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)337-5500plloyd@xodusmedical.com

Regulatory Flags#

DUNS number
868042664
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
20787551041389LPK10033 Lateral Positioning KitLPK10033LPK100332026-01-20
20787551041396LPK10034 Lateral Positioning KitLPK10034LPK100342026-01-20
2078755104010830250 Pink Pad - Loop Strap 29"30250302502025-07-16
20787551041228SPK10488 Jackson KitSPK10488SPK104882025-07-16
20787551041235PBK10008 Pegboard KitPBK10008PBK100082025-07-16
20787551041242SPK11661 Wilson Frame Positioning KitSPK11661SPK116612025-07-16
20787551041259SPK11649 Jackson Table Positioning KitSPK11649SPK116492025-07-16
20787551041266SPK11186 Surgical BackPack KitSPK11186SPK111862025-07-16
20787551041273NSCL25306 Custom Med Label PackNSCL25306NSCL253062025-07-16
20787551041280CL25257 Custom Med Label PackCL25257CL252572025-07-16
2078755103973740684 The Pink Pad XL - Advanced Trendelenburg Positioning Kit with Large DermaP40684406842025-04-16
20787551041082SPK11602 ProAxis Table KitSPK11602SPK116022025-04-16
20787551041105NSCL25293 Custom Med Label PackNSCL25293NSCL252932025-04-16
20787551041112NSCL25294 Custom Med Label PackNSCL25294NSCL252942025-04-16
2078755104112940688 XL Advanced Trendelenburg Positioning Kit - Biodegradable40688406882025-04-16
20787551041136SPK11632 Jackson KitSPK11632SPK116322025-04-16
20787551041143CL25296 Custom Med Label PackCL25296CL252962025-04-16
20787551041150SPK11639 Wilson Table KitSPK11639SPK116392025-04-16
20787551041167SPK11638 Jackson Table KitSPK11638SPK116382025-04-16
20787551041174SPK11640 Surgical BackPack KitSPK11640SPK116402025-04-16

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Primary DI, Brand, Company table
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