FDA.reportPublic FDA data

TruLim Length Indicating Device

Primary DI
40816286021084
Brand
TruLim Length Indicating Device
Company
BOEHRINGER LABORATORIES, LLC
Model
5010
Catalog number
5010
Device description
TruLim Length Indicating Device
Published
2022-06-21
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTYTape, Measuring, Rulers And Calipers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40816286021084PackageGS16In Commercial Distribution
10816286021083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4081628602108440816286021084
1081628602108310816286021083

GMDN Terms#

Term, Definition table
TermDefinition
Medical ruler, single-useA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be bendable to fit on the measured surfaces. It is not dedicated to wound measurements. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
610-278-0900info@boehringerlabs.com

Regulatory Flags#

DUNS number
079991657
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816286021199Boehringer Venturi Oxygen Valve Inlet39602026-09-22
10816286021182Boehringer Surgical Suction Device50302025-11-24
20816286021189Boehringer Surgical Suction Device50302025-11-24
10816286021175UpLivt 52002025-07-16
70816286021177UpLivt 52002025-07-16
10816286021120BOEHRINGER® ViSiGi Lux 36 Fr5336SB2025-05-20
10816286021137BOEHRINGER® ViSiGi Lux 40 Fr5340SB2025-05-20
30816286021124BOEHRINGER® ViSiGi Lux 36 Fr5336SB2025-05-20
30816286021131BOEHRINGER® ViSiGi Lux 40 Fr5340SB2025-05-20
10816286021151BOEHRINGER® CareDry™ Male System76802024-12-31
20816286021158BOEHRINGER® CareDry™ Male System76802024-12-31
10816286021168BOEHRINGER® Offset Mount - Four Inches90612024-12-31
10816286021076BOEHRINGER® CareDry™ System76602021-11-01
10816286020659BOEHRINGER® Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System52502016-08-01
10816286021083TruLim Length Indicating Device501050102022-06-21
10816286020932BOEHRINGER® Smoke Removal System57002020-02-01
10816286020079BOEHRINGER® Care 4™ Suction Regulator, Intermittent/Continuous, 0-200, off/ cont384438442016-08-01
10816286021144BOEHRINGER® CareDry™ System76652023-12-29
20816286021141BOEHRINGER® CareDry™ System76652023-12-29
10816286020949BOEHRINGER® CareDry™ Regulator PST763076302020-01-15

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